You are on page 1of 38

Dr. Shiva Murthy N.MBBS, MD, MBA, CEIM. Head, Clinical Pharmacology Unit A CRO in New Delhi Area shivuindia@yahoo.

com

This presentation is only for education purpose only. Not for commercial sale.

FUNDAMENTALS OF ICH GCP

compiled by Dr. Shiva Murthy N, shivuindia@yahoo.com

compiled by Dr. Shiva Murthy N, shivuindia@yahoo.com

shivuindia@yahoo. Shiva Murthy N.com .compiled by Dr.

.

recording and reporting trials that Involve the participation of human subjects. shivuindia@yahoo. Consistent with the principles that have their origin in the Declaration of Helsinki. Shiva Murthy N. compiled by Dr.com . conducting. safety and well-being of trial subjects are protected.Good Clinical Practice (GCP) is an International Ethical and scientific Quality standard for Designing. Compliance with this standard provides Public assurance that the Rights. and that the Clinical trial data are credible.

compiled by Dr. shivuindia@yahoo.The objective of this ICH GCP Guideline is to provide a Unified standard for the ▪ European Union (EU). ▪ Japan and ▪ the United States To facilitate The mutual acceptance of Clinical data by The regulatory authorities in these jurisdictions. Shiva Murthy N.com .

and The United States. Japan. shivuindia@yahoo. The Nordic countries and The World Health Organization (WHO). as well as those of Australia.com . compiled by Dr. Shiva Murthy N.The guideline was developed with consideration of the current good clinical practices of the European Union. Canada.

THE PRINCIPLES OF ICH GCP compiled by Dr. Shiva Murthy N. shivuindia@yahoo.com .

and that are Consistent with GCP and The applicable Regulatory requirement(s). Shiva Murthy N. shivuindia@yahoo.Clinical trials should be conducted in accordance with the Ethical principles that have their origin in The Declaration of Helsinki.com . compiled by Dr.

Shiva Murthy N.com .Before a trial is initiated. shivuindia@yahoo. compiled by Dr. Foreseeable risks and Inconveniences should be Weighed against The anticipated benefit for The individual trial subject and Society A trial should be initiated and continued only if The anticipated benefits justify the risks.

The rights. compiled by Dr. Safety. shivuindia@yahoo.com . and Well-being of the trial subjects are The most important Considerations and Should prevail over interests of science and society. Shiva Murthy N.

compiled by Dr. shivuindia@yahoo. Shiva Murthy N.com .The available Nonclinical and Clinical information on An investigational product should be Adequate to support The proposed clinical trial.

Detailed Protocol. and Described in a clear. shivuindia@yahoo. Shiva Murthy N.com .Clinical trials should be Scientifically sound. compiled by Dr.

compiled by Dr. shivuindia@yahoo.com . Shiva Murthy N.A trial should be conducted in Compliance with the Protocol that has received prior Institutional review board (IRB)/independent ethics committee (IEC) Approval/Favourable opinion.

Shiva Murthy N. shivuindia@yahoo. and Medical decisions Made on behalf of. of a qualified dentist. compiled by Dr. subjects Should always be the responsibility of a qualified physician or. When appropriate.The medical care given to.com .

Training. and Experience To perform his or her respective task(s). Shiva Murthy N.com . shivuindia@yahoo. compiled by Dr.Each individual involved in conducting a trial should be Qualified by Education.

shivuindia@yahoo. compiled by Dr. Shiva Murthy N.com .Freely given Informed consent should be obtained from Every subject Prior to clinical trial participation.

Handled.All clinical trial information should be Recorded.com . Shiva Murthy N. shivuindia@yahoo. Not documented – Means not done compiled by Dr. Interpretation and Verification. and Stored in a way that Allows its accurate Reporting.

The confidentiality of records That could identify subjects should be Protected. shivuindia@yahoo. compiled by Dr.com . Respecting the privacy and Confidentiality rules In accordance with The applicable regulatory requirement(s). Shiva Murthy N.

They should be used In accordance with the approved protocol. Shiva Murthy N.com . Handled. shivuindia@yahoo. and Stored In accordance with Applicable good manufacturing practice (GMP).Investigational products should be Manufactured. compiled by Dr.

shivuindia@yahoo. Shiva Murthy N.com .Systems With procedures That Assure The Quality of Every Aspect of the Trial Should be Implemented. compiled by Dr.

shivuindia@yahoo. Shiva Murthy N.RECENT ETHICAL CONCERNS compiled by Dr.com .

2013 First Published: 02:07 IST(23/10/2013) | Last Updated: 13:21 IST(23/10/2013) compiled by Dr. Hindustan Times Indore/New Delhi. Shiva Murthy N.com . shivuindia@yahoo. October 23.Clinical trials and many errors Nida Khan and HT Correspondent.

Shiva Murthy N.com .compiled by Dr. shivuindia@yahoo.

compiled by Dr. shivuindia@yahoo.com . Shiva Murthy N.

shivuindia@yahoo.Amendments to Drugs and Cosmetic act 1940 Rule no 122 DAB – GSR 63(E) 30th Jan 2013 – Compensation in case of Injury or death during clinical trials Rule no 122 DAC – GSR 63(E) 01st Feb 2013 – Permission to conduct clinical trial Rule no 122 DD – GSR 72(E) 8th Feb 2013 – Regulation of IECs and their registrations compiled by Dr.com . Shiva Murthy N.

Harmonization in reporting of SAEs done F.2013 .com . Shiva Murthy N.System of Pre-screening for submission of reports of ANNEXURE-A .02.No.CHECKLIST FOR SUBMISSION OF SERIOUS ADVERSE EVENT REPORT (SAE) OCCURRING IN CLINICAL TRIAL SAEs to CDSCO compiled by Dr. shivuindia@yahoo. 12-01/13-DC (Pt-13A ) –Effective date 18.

Shiva Murthy N.60 lacs depending on the age of the deceased and the risk factor. shivuindia@yahoo. However. a fixed amount of Rs.FORMULA TO DETERMINE THE QUANTUM OF COMPENSATION IN THE CASES OF SERIOUS ADVERSE EVENTS (SAEs) OF DEATHS OCCURRING DURING CLINICAL TRIALS under the Chairmanship of DR.com .4 lacs to a maximum of Rs. A K Agarwal the compensation amount will vary from a minimum of Rs.73. in case of patients whose expected mortality is 90 % or more within 30 days. 2 lac should be given compiled by Dr.

shivuindia@yahoo.com .Report of the prof. clinical trials and banning of drugs July 2013 compiled by Dr. Ranjit Roy Chaudhury Expert Committee To formulate policy and guidelines for approval of new drugs. Shiva Murthy N.

com .compiled by Dr. Shiva Murthy N. shivuindia@yahoo.

Shiva Murthy N.No./2013 DCGI Dated 19/Nov/2013 Mandatory to Audio – Video Recording of ICF process compiled by Dr.GCT/20/SC/Clin.F. shivuindia@yahoo.com .

Any Handy Cam can help to record the ICF process Minimum of two cameras should be available to capture simultaneous activities Operation method – Two parts Study information sheet – Group presentation and question and answer session Informed consent – One to one discussion and final affirmation compiled by Dr. Shiva Murthy N.com . shivuindia@yahoo.

com .10-15 page document.Study information sheet .more than one patient/volunteer/subject can attend this presentation) compiled by Dr. Shiva Murthy N. shivuindia@yahoo. Provides details of the study ▪ Group presentation .

Shiva Murthy N. shivuindia@yahoo.com .this should be done one to one in presence of witness / guardian of the volunteer/subject/patient Witness also can be present in this meeting and sign the consent form for illiterate / minor/ vulnerable subjects compiled by Dr. One to one presentation .Informed consent – Final affirmation of the subject and certify that he is in complete knowledge of the study and all queries are clarified.

Shiva Murthy N.Both Group presentation One to one presentation Should be AV captured and stored indefinitely compiled by Dr.com . shivuindia@yahoo.

shivuindia@yahoo.Advantages compiled by Dr. Shiva Murthy N.com Saves investigators from future litigations Can act as evidence if the subject sues in court Provides transparency Protects vulnerable subjects from risk Protects industry from media and socialist false claims Sponsor should be paying for it Disadvantage Additional step and responsibility to do this work Maintain the confidentiality and long term storage Practical aspects of administration .

Thank you compiled by Dr. Shiva Murthy N.com . shivuindia@yahoo.